OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE (OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCH
Failed Dissolution Specifications — OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE (OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE)
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Failed Dissolution Specifications.
The recalled product
- Product
- OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE (OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE)
- Brand
- OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- MACLEODS PHARMA USA, INC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 12251163A
- Exp 05-31-2027
- b) 12251163B
UPCs (2)
- 0333342247070
- 0333342245076
Distribution
Distributed nationwide across the United States.
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